Recall Z-1462-2015— Laax, Inc.

Name: FDA recall Z-1462-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-25

Class I · Terminated

Class I FDA medical device recall by Laax, Inc., initiated 2015-03-25, terminated 2017-03-17. It names one FDA 510(k) clearance: K111064. Product: TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).. Reason: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener..

Recalling firm: Laax, Inc.
Classification: Class I
Status: Terminated
Initiated: 2015-03-25
Terminated: 2017-03-17
Firm location: Livermore, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111064 — TIGERPAW SYSTEM IILaax, Inc.·cleared 2011-05-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

Reason for recall

Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

Data sourced from openFDA. This site is unofficial and independent of the FDA.